A Study of CellCept (Mycophenolate Mofetil) in Lung Transplant Recipients

Lung Transplantation Clinical Trial

Official title:

Pharmacokinetics of Mycophenolate Mofetil in de Novo Lung Allograft Recipients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01014442
• Other study ID #: ML22608
• Secondary ID: 2009-012231-15
• Status: Completed
• Phase: Phase 3
• First received: November 16, 2009
• Last updated: July 22, 2015
• Start date: January 2010
• Est. completion date: June 2012

Study information

• Verified date: July 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Bundesinstitut für Arzneimittel und Medizinprodukte
• Study type: Interventional

Clinical Trial Summary

This open-label, single center study will assess the pharmacokinetics, efficacy and safety of Cellcept in lung allograft recipients. Patients will be split into 2 groups according to the original disease: group A (cystic fibrosis) and group B (chronic obstructive pulmonary disease, emphysema, idiopathic pulmonary fibrosis, alpha-1 antitrypsin deficiency). All patients will receive CellCept orally, 1.5g twice daily on days 1-30 post transplantation, and 1g twice daily on days 31-90. Anticipated time on study treatment is 90 days, and target sample size is 50-100 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patients, >/=18 years of age

• primary single or bilateral lung allograft

• original disease cystic fibrosis, COPD, emphysema, idiopathic pulmonary fibrosis or alpha-1 antitrypsin deficiency

Exclusion Criteria:

• lung allograft retransplantation

• multiple organ transplantation

• severe gastrointestinal disorder

• malignancies or history of malignancy

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Transplantation

Intervention

Drug:
• mycophenolate mofetil
1.5 g PO BID from Days 1 to 30 post-transplantation, 1 g PO BID Days 31 to 90 post-transplantation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics and metabolic ratios: Cmax, Tmax, Cmin, V2, AUC for MPA, MPAG, AcMPAG and free MPA		days 4, 8, 20 and 90	No
Secondary	Efficacy: pulmonary function, alloimmune status, peripheral T-cell phenotype		days 4, 8, 20 and 90, pulmonary function day 90	No
Secondary	Safety: AEs, laboratory parameters, opportunistic infections		throughout study, laboratory assessments days 4, 8, 20 and 90	No